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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collimator, Manual, Radiographic
510(k) Number K840678
Device Name UXM MODEL 8188
Applicant
Universal X-Ray
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Universal X-Ray
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1610
Classification Product Code
IZX  
Date Received02/15/1984
Decision Date 03/16/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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